CHEMICAL, BIOLOGICAL AND MICRO-BIOLOGICAL TESTING
Through chemical, biological or microbiological testing (analysis) companies, authorities or other parties can get chemical, biological and microbiological parameters of a product/subject established or a test taken from food or in the surrounding environment. In many instances these parameters and properties must meet requirements in law or specifications set in other ways.
Special schemes:
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For laboratories performing environmental measurements, there are requirements to the quality of analysis, which must be fulfilled. These requirements are reflected in the at all times current executive order from the Ministry of the Environment on quality requirements to environmental measurements.
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Laboratories performing emission measurements will be assessed against the requirements in CEN/TS 15675: 2007. Air quality - Measurement of stationary source emissions. This technical specification is a sector-specific interpretation of ISO 17025.
Laboratories can be accredited to testing in a wide range of test areas cf. accreditation provision AB 3, annex 1:
Testing Areas and Product Areas
Testing Areas
- Biological and biochemical
- Chemical
- Forensic*
- Micro-biological
- Ionising radiation and radio chemistry*
- Sampling*
- Sensory
Areas marked (*) will also occur within physical, mechanical and electrical testing.
Product Areas
- Biological material
- Chemicals
- Construction materials
- Environmental samples
- Food products
- Pharmaceutical products
- Toys, sports and rides
- Farm products
RULES AND REGULATIONS:
Below are links or references to documents for the specific scheme.
EXECUTIVE ORDERS
ACCREDITATION STANDARD
- DS/EN ISO/IEC 17025, 2017 General requirements for the competence of testing and calibration laboratories.
ACCREDITATION REGULATIONS
- AB 1 General regulation for accreditation of companies
- AB 2 DANAK’s accreditation mark and reference to accreditation
- AB 3 Accreditation of laboratories
- AB10 Accreditation of laboratories to a flexible scope of accreditation (new edition in Danish only)
- AB 13: Evaluation and reporting of uncertainty of measurement by quantitative chemical and microbiological testing
- AB 18: Accreditation as basis for notification
GUIDELINES
In addition to the above requirement documents, that testing laboratories must comply with, there are a number of international guidelines that are relevant to the accredited laboratories, and implemented through the accreditation regulations.
- EA-4/09:2017: Accreditation for Sensory Testing Laboratories.*
- EA-4/14:2003: The Selection and Use of Reference Materials
- EA-4/18:2021: Guidance on the level and frequency of proficiency testing participation
- ILAC G8:09/2019: Guidelines on Decision Rules and Statements of Conformity
- ILAC G17:01/2021 ILAC Guidelines for Measurement Uncertainty in Testing
- ILAC G19:06/2022 Modules in a Forensic Science Process
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ILAC G24:2022: Guidelines for the determination of recalibration intervals of measuring equipment
The guidelines marked (*) are specific to a certain sector and are only relevant for laboratories doing testing within these scopes.
ACCREDITATION MESSAGES
Please note that accreditation messages are only issued in Danish.
Various accreditation messages have also been published that guide and describe the assessment practice and issues relevant to accredited testing laboratories:
1. ACCREDITATION MESSAGES - AMF
- AMF 04: Processing non-conformities
2. AML - FOR ALL TYPES OF LABORATORIES
- AML 02: Extend of accreditation scope
- AML 03: Use of computer systems in accredited laboratories
- AML 07: Securing independence and impartiality
- AML 10: Surveillance of the general management system of multiple accreditations
- AML 17: Internal audit and management evaluation
- AML 18: Formulation of scope of accreditation
- AML 22: Submitting electronic management systems
- AML 23: Reference to DANAK and accreditation and specification of traceability
- AML 28: Calibration and control of measuring equipment
- AML 29: Change of location
3. AML P - FOR TESTING LABORATORIES
- AML P 01: Accreditation of laboratories according to the executive order from the Ministry of Environment on quality requirements for environmental measurements**
- AML P 06: EA term 'Product' to be deleted from lists of methods per 1 March 2018
** applies to laboratories wishing to carry out sampling or perform environmental analysises covered by the Ministry of the environment Decree on quality requirements to environmental measurements.